NCT03877757

Brief Summary

Family Planning Elevated (FPE) is a statewide contraceptive initiative with two primary aims: 1) supporting existing and proposed legislative policy that expands family planning services in Utah among low-income individuals covered by contraceptive legislation (currently individuals at ≤100% federal poverty) and 2) demonstrating additional existing service need among low-income individuals who currently fall in the contraceptive coverage gap (101%-250% federal poverty). Family Planning Elevated provides contraceptive grants, education and training, and technical assistance on comprehensive contraceptive care to participating clinics. The purpose of this evaluation is to assess the effect of FPE on clinic-level family planning service delivery among low-income women who fall in the contraceptive coverage gap compared to those receiving services from matched control clinics which did not receive the intervention. To assess these effects, FPE will collect monthly family planning service delivery data from both intervention and control clinics, beginning 12 months prior to the FPE intervention, and following for 12 months after the FPE intervention ends. A difference-in-difference analysis will compare trends and level-changes in family planning services provided to intervention and control groups.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

5.4 years

First QC Date

March 7, 2019

Last Update Submit

December 9, 2024

Conditions

Keywords

Family PlanningImplementation scienceEvaluationContraceptive initiative

Outcome Measures

Primary Outcomes (1)

  • Change in total family planning services provided to women ages 18-49, as measured by monthly service delivery report

    Family planning services are defined as all family planning-related E/M, CPT, and HCPC codes within the FPE monthly service delivery report

    12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention

Secondary Outcomes (1)

  • Changes in total long-acting reversible contraceptive services (LARC) provided to all women ages 18-49, as measured by monthly service delivery report

    12 months prior to FPE intervention start, for the 24-month intervention period, and for 12 months post-intervention

Study Arms (2)

Family Planning Elevated Contraceptive Access Clinics Program

This group consists of community clinics who apply and are accepted for FPE CAP membership during the Family Planning Elevated initiative. These clinics will receive the intervention and will provide monthly service delivery data to the FPE evaluation team.

Control Clinics

This group consists of non-participating community clinics matched on clinic size, geography, and client populations who are not interested in participating in the initiative but are willing to provide monthly service delivery data to the FPE evaluation team.

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWomen of reproductive age
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The intervention occurs at the clinic level. Participating clinics are Utah health systems and individual clinics across Utah.

You may qualify if:

  • Women of reproductive age (age 18-50) who visited the intervention or control clinic within the allotted time frame.

You may not qualify if:

  • Under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

  • Cohen SR, Baayd J, Garcia G, Quade C, Gero A, Ekey M, Poggio C, Simmons R. Facility-based simulation as a programmatic tool for implementing a statewide contraceptive initiative. BMC Health Serv Res. 2022 Jul 29;22(1):965. doi: 10.1186/s12913-022-08332-4.

  • Baayd J, Simmons RG. Protocol for a process evaluation of Family Planning Elevated: a statewide initiative to improve contraceptive access in Utah (USA). BMJ Open. 2020 Oct 1;10(10):e038049. doi: 10.1136/bmjopen-2020-038049.

Study Officials

  • Rebecca Simmons, PhD

    University of Utah, Department of OBGYN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 18, 2019

Study Start

February 1, 2019

Primary Completion

June 14, 2024

Study Completion

December 28, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations